Lenalidomide fresenius kabi

Package leaflet: Information for the patient

Lenalidomide Fresenius Kabi, 2.5 mg, hard capsules
Lenalidomide Fresenius Kabi, 5 mg, hard capsules
Lenalidomide Fresenius Kabi, 7.5 mg, hard capsules
Lenalidomide Fresenius Kabi, 10 mg, hard capsules
Lenalidomide Fresenius Kabi, 15 mg, hard capsules
Lenalidomide Fresenius Kabi, 20 mg, hard capsules
Lenalidomide Fresenius Kabi, 25 mg, hard capsules
Lenalidomidum
Please read carefully the entire leaflet before using this medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

1. What Lenalidomide Fresenius Kabi is and what it is used for
2. Important information before taking Lenalidomide Fresenius Kabi
3. How to take Lenalidomide Fresenius Kabi
4. Possible side effects
5. How to store Lenalidomide Fresenius Kabi
6. Contents of the pack and other information

1. What Lenalidomide Fresenius Kabi is and what it is used for

Lenalidomide Fresenius Kabi contains the active substance "lenalidomide". This medicine belongs to a group of medicines that affect the function of the immune system.
Lenalidomide Fresenius Kabi is used in adult patients for the treatment of:

• multiple myeloma,
• myelodysplastic syndromes,
• mantle cell lymphoma,
• follicular lymphoma.

Multiple myeloma
Multiple myeloma is a type of cancer that affects a certain type of white blood cells called plasma cells. These cells accumulate in the bone marrow and divide uncontrollably. This may lead to damage of bones and kidneys.
Multiple myeloma is essentially incurable. However, it is possible to achieve temporary significant reduction or elimination of signs and symptoms of the disease. This is called "remission".
Newly diagnosed multiple myeloma – in patients after bone marrow transplantation
In this indication, after achieving an adequate post-transplant status, Lenalidomide Fresenius Kabi is used as maintenance therapy without other drugs.
Newly diagnosed multiple myeloma – in patients not eligible for bone marrow transplantation
Lenalidomide Fresenius Kabi is used in combination with other medicines, including:

• a chemotherapy drug called "bortezomib";
• an anti-inflammatory drug called "dexamethasone";
• a chemotherapy drug called "melphalan"; and
• an immunosuppressive drug called "prednisone". The patient starts treatment with additional medicines and then continues treatment with Lenalidomide Fresenius Kabi alone.

If the patient is 75 years of age or older, or has moderate to severe kidney problems, the doctor will perform thorough assessments before starting treatment.
Multiple myeloma – in previously treated patients
Lenalidomide Fresenius Kabi is used in combination with an anti-inflammatory drug called "dexamethasone".
Lenalidomide Fresenius Kabi may stop the progression of signs and symptoms of multiple myeloma.
It has also been shown to delay relapse of multiple myeloma after treatment.

Myelodysplastic syndromes (MDS)
Myelodysplastic syndromes are a group of various blood and bone marrow disorders. Abnormal blood cells are present, which do not function properly. Patients may experience various subjective and objective symptoms, including low number of red blood cells (anaemia), need for blood transfusions, and risk of infection.
Lenalidomide Fresenius Kabi, as monotherapy, is used in the treatment of adult patients diagnosed with myelodysplastic syndromes, if all of the following conditions are met:

• the patient requires regular blood transfusions due to low number of red blood cells ("transfusion-dependent anaemia");
• the patient has an abnormality in bone marrow cells called "isolated cytogenetic abnormality of deletion 5q". This means that the patient's body does not produce enough healthy blood cells;
• the patient has previously received other treatments that were inappropriate or insufficiently effective.

Lenalidomide Fresenius Kabi may increase the number of healthy blood cells produced by the body by reducing the number of abnormal cells:

• this may lead to a reduction in the number of required blood transfusions. It may even become possible to discontinue transfusions altogether.

Mantle cell lymphoma (MCL)
Mantle cell lymphoma is a cancer affecting part of the immune system (lymphatic tissue). It attacks a certain type of white blood cells called B-lymphocytes or B-cells. Mantle cell lymphoma is a disease characterized by uncontrolled growth of B-lymphocytes, leading to their accumulation in lymphatic tissue, bone marrow, or blood.
Lenalidomide Fresenius Kabi, as monotherapy, is used in the treatment of adult patients who have been previously treated with other medicines.

Follicular lymphoma (FL)
Follicular lymphoma is a slowly growing malignant cancer affecting B-lymphocytes. These are a type of white blood cells that help the body fight infections. In patients with follicular lymphoma, excessive numbers of B-lymphocytes may accumulate in the blood, bone marrow, lymph nodes, and spleen.
Lenalidomide Fresenius Kabi is taken together with another medicine called "rituximab" for the treatment of adult patients with previously treated follicular lymphoma.

How Lenalidomide Fresenius Kabi works
Lenalidomide Fresenius Kabi works by affecting the function of the immune system and directly attacking cancer cells. The medicine acts in several different ways:

• by inhibiting the growth of cancer cells;
• by inhibiting the development of blood vessels in the tumour;
• by stimulating part of the immune system to attack cancer cells.

2. Important information before taking Lenalidomide Fresenius Kabi

Before starting treatment with Lenalidomide Fresenius Kabi, carefully read
the package leaflets of all medicines taken in combination with Lenalidomide Fresenius Kabi.
When not to take Lenalidomide Fresenius Kabi:

• If the patient is pregnant, suspects she is pregnant, or plans to become pregnant, because it is believed that Lenalidomide Fresenius Kabi may be harmful to the unborn child (see section 2 "Pregnancy, breastfeeding and contraception – information for women and men").
• If the patient could become pregnant, unless she uses all required contraceptive measures (see section 2 "Pregnancy, breastfeeding and contraception – information for women and men"). If the patient could become pregnant, the doctor will always document at the time of prescription that necessary precautions have been taken and will confirm this with the patient.
• If the patient is allergic to lenalidomide or any of the other ingredients of this medicine (listed in section 6). If an allergy is suspected, consult a doctor for advice.

If any of these points apply to the patient, Lenalidomide Fresenius Kabi must not be used. In case of doubt, consult a doctor.
Warnings and precautions
Before starting to take Lenalidomide Fresenius Kabi, discuss this with the doctor,
pharmacist, or nurse if the patient:

• Has previously had blood clots – this means an increased risk of developing blood clots in veins and arteries during treatment;
• Has any signs of infection, such as cough or fever;
• Currently has or has previously had a viral infection, particularly varicella-zoster virus, hepatitis B, or HIV. In case of doubt, consult a doctor. Treatment with Lenalidomide Fresenius Kabi may reactivate viruses in patients previously infected, leading to recurrence of infection. The doctor will check whether the patient has previously had hepatitis B;
• Has kidney problems – the doctor may adjust the dose of Lenalidomide Fresenius Kabi;
• Has had a heart attack (heart attack), has ever had a blood clot, smokes, has high blood pressure, or has high cholesterol levels;
• Experienced allergic reactions while taking thalidomide (another medicine used in the treatment of multiple myeloma), such as rash, itching, swelling, dizziness, or difficulty breathing;
• Previously experienced a combination of any of the following symptoms: widespread rash, skin redness, high fever, flu-like symptoms, elevated liver enzymes, blood abnormalities (eosinophilia), enlarged lymph nodes – these are symptoms of a severe skin reaction known as drug reaction with eosinophilia and systemic symptoms (DRESS), also called drug hypersensitivity syndrome (see also section 4 "Possible side effects").

If any of the above points apply to the patient, consult a doctor, pharmacist, or nurse before starting treatment.
Immediately inform the doctor or nurse if, at any time during or after treatment, the patient experiences:

• Vision disturbances, loss of vision, double vision, difficulty speaking, weakness in the arm or leg, change in gait or balance disturbances, persistent numbness, reduced sensation or loss of sensation, memory loss or disorientation. These may be symptoms of a serious and potentially fatal brain disease called progressive multifocal leukoencephalopathy (PML). If the patient had such symptoms before treatment with lenalidomide, inform the doctor of any changes.
• Shortness of breath, fatigue, dizziness, chest pain, rapid heartbeat, or swelling of the legs or ankles. These may be symptoms of a serious condition known as pulmonary hypertension (see section 4).

Tests and examinations
Before and during treatment with Lenalidomide Fresenius Kabi, the patient will undergo regular blood tests because Lenalidomide Fresenius Kabi may reduce the number of blood cells that help fight infection (white blood cells) and help blood clot (platelets). The doctor will schedule blood tests:

• Before treatment,
• Weekly for the first 8 weeks of treatment,
• Then at least once a month.

Before starting lenalidomide treatment and during treatment, the patient may be evaluated for circulatory and respiratory problems.
Patients with myelodysplastic syndromes taking Lenalidomide Fresenius Kabi
If the patient has myelodysplastic syndromes, there is an increased risk of developing a serious disease called acute myeloid leukaemia. Furthermore, it is not known how Lenalidomide Fresenius Kabi affects the likelihood of developing acute myeloid leukaemia. Therefore, the doctor may perform tests and check for signs that better predict the risk of acute myeloid leukaemia during treatment with Lenalidomide Fresenius Kabi.
Patients with mantle cell lymphoma taking Lenalidomide Fresenius Kabi
The doctor will request blood tests:

• Before treatment,
• Weekly for the first 8 weeks (2 cycles) of treatment,
• Then every 2 weeks during cycles 3 and 4 (more information in section 3 "Treatment cycle"),
• Then at the beginning of each cycle and
• At least once a month.

Patients with follicular lymphoma taking Lenalidomide Fresenius Kabi
The doctor will request blood tests:

• Before treatment,
• Weekly for the first 3 weeks (1 cycle) of treatment,
• Then every 2 weeks during cycles 2 to 4 (more information in section 3 "Treatment cycle"),
• Then at the beginning of each cycle and
• At least once a month.

The doctor may perform a test to determine whether the patient has a large amount of tumour tissue in the body, including bone marrow. This may lead to a situation where tumour tissue begins to die, causing abnormal increases in various substances in the blood, potentially leading to kidney failure (a condition known as tumour lysis syndrome).
The doctor may examine the patient to check for skin changes such as red spots or rash.
The doctor may adjust the dose of Lenalidomide Fresenius Kabi or discontinue treatment based on blood test results and the patient's overall condition. If the disease was recently diagnosed, the doctor may also consider the patient's age and other pre-existing conditions when assessing treatment.
Blood donation
During treatment and for at least 7 days after treatment ends, the patient must not donate blood.
Children and adolescents
Lenalidomide Fresenius Kabi is not recommended for use in children and adolescents under 18 years of age.
Elderly patients and patients with kidney problems
If the patient is 75 years of age or older, or has moderate to severe kidney problems, the doctor will perform thorough evaluations before starting treatment.
Lenalidomide Fresenius Kabi and other medicines
Inform the doctor or nurse about all medicines currently taken or recently taken by the patient. This is necessary because Lenalidomide Fresenius Kabi may affect the action of other medicines. Likewise, other medicines may affect the action of Lenalidomide Fresenius Kabi.
In particular, inform the doctor or nurse if the patient is taking the following medicines:

• Certain contraceptives, such as oral contraceptives, as they may become ineffective;
• Certain medicines used for heart problems, such as digoxin;
• Certain medicines used to thin the blood, such as warfarin.

Pregnancy, breastfeeding and contraception – information for women and men
Pregnancy
For women taking Lenalidomide Fresenius Kabi

• Lenalidomide Fresenius Kabi must not be used if the patient is pregnant, as it is believed to be harmful to the unborn child.
• Women must not become pregnant while taking Lenalidomide Fresenius Kabi. Therefore, women who could become pregnant must use an effective method of contraception (see "Contraception").
• If the patient becomes pregnant during treatment with Lenalidomide Fresenius Kabi, treatment must be stopped immediately and the doctor informed.

For men taking Lenalidomide Fresenius Kabi

• If the male patient's partner becomes pregnant during treatment with Lenalidomide Fresenius Kabi, he must immediately inform the doctor. The partner should seek medical advice.
• Men must also use an effective method of contraception (see "Contraception").

Breastfeeding
Breastfeeding must not be used during treatment with Lenalidomide Fresenius Kabi, as it is not known whether Lenalidomide Fresenius Kabi passes into human milk.
Contraception
Women taking Lenalidomide Fresenius Kabi
Before starting treatment, ask the doctor about the possibility of becoming pregnant, even if the patient considers it unlikely.
Women who could become pregnant:

• Will undergo doctor-supervised pregnancy tests (before each treatment, at least every 4 weeks during treatment, and at least 4 weeks after treatment ends), except in cases where the fallopian tubes have been cut and blocked to prevent the egg from reaching the uterus (tubal sterilization) OR
• Must use effective methods of contraception for at least 4 weeks before starting treatment, during treatment, and for at least 4 weeks after treatment ends. The doctor will advise the patient on appropriate contraceptive methods.

Men taking Lenalidomide Fresenius Kabi
Lenalidomide Fresenius Kabi passes into human semen. If the patient's partner is pregnant or could become pregnant and is not using an effective contraceptive method, the patient must use a condom during treatment and for at least 7 days after treatment ends. This applies even to men who have had a vasectomy. During treatment and for at least 7 days after treatment ends, the patient must not donate semen.
Driving and using machines
Do not drive or operate machinery if the patient experiences dizziness, fatigue, drowsiness, balance disturbances due to vertigo, or blurred vision after taking Lenalidomide Fresenius Kabi.
Lenalidomide Fresenius Kabi contains lactose
Lenalidomide Fresenius Kabi contains lactose. If the patient has previously been diagnosed with intolerance to certain sugars, consult a doctor before taking Lenalidomide Fresenius Kabi.
Lenalidomide Fresenius Kabi contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium per capsule, meaning the medicine is considered "sodium-free".

3. How to take Lenalidomide Fresenius Kabi

Lenalidomide Fresenius Kabi must be dispensed by medical professionals experienced in the treatment of multiple myeloma, MDS, MCL, or FL.

• When Lenalidomide Fresenius Kabi is used to treat multiple myeloma in patients who are not eligible for bone marrow transplantation or who have previously received other treatment, the medicine should be used in combination with other drugs (see section 1, "What Lenalidomide Fresenius Kabi is and what it is used for").
• When Lenalidomide Fresenius Kabi is used to treat multiple myeloma in patients after bone marrow transplantation or in patients with MDS or MCL, the medicine should be used as monotherapy.
• When Lenalidomide Fresenius Kabi is used to treat follicular lymphoma, it should be taken together with another medicine called rituximab.

Lenalidomide Fresenius Kabi should always be taken exactly as prescribed by the doctor. In case of doubt, consult your doctor or pharmacist.
If you are taking Lenalidomide Fresenius Kabi together with other medicines, you should read the package leaflet included with those medicines to obtain information about their use and effects.

Treatment cycle
Lenalidomide Fresenius Kabi is taken on specific days during a period of three weeks (21 days).

• Each 21-day period is called a "treatment cycle".

• Depending on the day of the cycle, you may take one or more medicines. However, on certain days you will not take any medicines.

• After completing each 21-day cycle, you should start a new 21-day "cycle".
  OR
  Lenalidomide Fresenius Kabi is taken on specific days during a period of four weeks (28 days).

• Each 28-day period is called a "treatment cycle".

• Depending on the day of the cycle, you may take one or more medicines. However, on certain days you will not take any medicines.

• After completing each 28-day cycle, you should start a new 28-day "cycle".

Recommended dose of Lenalidomide Fresenius Kabi
Before starting treatment, your doctor will inform you:

• of the dose of Lenalidomide Fresenius Kabi you should take;
• of the dose of other medicines you should take in combination with Lenalidomide Fresenius Kabi, if combination therapy is required;
• on which days of the cycle to take which medicines.

How and when to take Lenalidomide Fresenius Kabi

• Swallow the capsule whole, preferably with water.
• Do not break, open, or chew the capsules. If the powder from a damaged Lenalidomide Fresenius Kabi capsule comes into contact with the skin, wash the skin immediately and thoroughly with soap and water.
• Healthcare professionals, caregivers, and family members should wear disposable gloves when handling the blister pack or capsules. Gloves should be carefully removed to avoid skin exposure, placed in a sealed polyethylene plastic bag, and disposed of according to local regulations. Hands should then be washed thoroughly with soap and water. Pregnant women or women who suspect they may be pregnant must not handle the blister pack or capsules.
• Capsules may be taken with or without food.
• Lenalidomide Fresenius Kabi should be taken at approximately the same time each day on which the dose is scheduled.

Taking this medicine
To remove a capsule from the blister pack:

• press only on one side of the capsule and push it through the foil;
• do not press on the center of the capsule, as this may damage it.

Duration of treatment with Lenalidomide Fresenius Kabi
Lenalidomide Fresenius Kabi is administered in treatment cycles; each cycle lasts 21 or 28 days (see above, "Treatment cycle"). Treatment cycles should continue until the doctor decides to discontinue therapy.

If you take more Lenalidomide Fresenius Kabi than prescribed
If you take more than the prescribed dose of Lenalidomide Fresenius Kabi, contact your doctor immediately.

If you miss a dose of Lenalidomide Fresenius Kabi
If you miss a scheduled dose of Lenalidomide Fresenius Kabi and

• less than 12 hours have passed since the scheduled time: take the capsule immediately;
• more than 12 hours have passed: do not take the missed capsule. Take the next capsule at the scheduled time on the following day.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If any of the following serious adverse reactions occur, stop taking Lenalidomide Fresenius Kabi
immediately and seek medical advice without delay – immediate treatment may be required:

• urticaria, rash, swelling of the eyes, lips or face, breathing difficulties or itching, which may be symptoms of severe allergic reactions known as angioedema and anaphylactic reaction;
• severe allergic reaction possibly starting as a rash in one area, spreading over the entire body and associated with significant skin peeling (Stevens-Johnson syndrome and/or toxic epidermal necrolysis);
• widespread rash, high fever, increased liver enzyme activity, blood abnormalities (eosinophilia), swollen lymph nodes and involvement of other organs (drug rash with eosinophilia and systemic symptoms, also known as “DRESS” or “drug hypersensitivity syndrome”). See also section 2.

Immediately inform your doctor if any of the following serious adverse reactions occur:

• fever, chills, sore throat, cough, mouth ulcers or any other signs of infection (including blood infections (sepsis));
• bleeding or bruising without injury;
• chest pain or leg pain;
• shortness of breath;
• bone pain, muscle weakness, confusion or fatigue, which may result from high calcium levels in the blood.

Lenalidomide Fresenius Kabi may reduce the number of white blood cells that fight infection,
as well as blood cells involved in blood clotting (platelets), which may lead to bleeding disorders,
such as nosebleeds and bruising. Lenalidomide Fresenius Kabi may also cause blood clots in veins (venous thrombosis).
Other adverse reactions
It should be noted that in a small number of patients, other types of cancer may develop, and the risk of this may potentially be increased by treatment with Lenalidomide Fresenius Kabi. Therefore, the treating physician should carefully evaluate the benefits and risks before prescribing Lenalidomide Fresenius Kabi to a patient.
Very common adverse reactions (may affect more than 1 in 10 people):

• reduction in red blood cells, which may lead to anaemia causing fatigue and weakness;
• skin rash, itching;
• muscle cramps, muscle weakness, muscle pain, muscle tenderness, bone pain, joint pain, back pain, limb pain;
• generalised swelling, including swelling of hands and feet;
• weakness, fatigue;
• flu and flu-like symptoms, including fever, muscle pain, headache, ear pain, cough and chills;
• numbness, tingling or burning sensation of the skin, pain in hands or feet, dizziness, tremor, decreased appetite, altered taste sensation;
• worsening of pain, enlargement or redness around a tumour;
• weight loss;
• constipation, diarrhoea, nausea, vomiting, abdominal pain, heartburn;
• low levels of potassium, calcium and/or sodium in the blood;
• underactive thyroid gland;
• leg pain (which may be a sign of thrombosis), chest pain or shortness of breath (which may be symptoms of blood clots in the lungs, known as pulmonary embolism);
• all types of infections, including sinus infection, lung infection and upper respiratory tract infection;
• shortness of breath;
• blurred vision;
• cloudy vision (cataract);
• kidney problems, including abnormal kidney function or inability to maintain normal kidney function;
• abnormal liver test results;
• increased liver function test values;
• changes in blood proteins leading to blood vessel swelling (vasculitis);
• increased blood sugar levels (diabetes);
• decreased blood sugar levels;
• headache;
• nosebleeds;
• dry skin;
• depression, mood changes, sleep disturbances;
• cough;
• low blood pressure;
• vague feeling of physical discomfort, malaise;
• painful inflammation of the mouth, dryness in the mouth;
• dehydration.

Common adverse reactions (may affect up to 1 in 10 people):

• breakdown of red blood cells (haemolytic anaemia);
• certain types of skin tumours;
• bleeding from gums, stomach or intestines;
• increased blood pressure, slow, fast or irregular heartbeat;
• increased levels of substances produced during normal and abnormal breakdown of red blood cells;
• increased levels of a protein indicating inflammation in the body;
• darkening of the skin; skin discolouration due to bleeding under the skin, usually caused by bruising; blood-filled skin swelling, bruises;
• increased uric acid levels in the blood;
• skin eruptions, skin redness, skin cracking, peeling or flaking, urticaria;
• excessive sweating, night sweats;
• difficulty swallowing, sore throat, voice quality problems or voice changes;
• nasal inflammation (rhinitis);
• passing significantly more or significantly less urine than normal, or inability to control the timing of urination;
• blood in the urine;
• shortness of breath, especially when lying down (which may be a sign of heart failure);
• erectile difficulties;
• stroke, fainting, dizziness (inner ear disorder causing a sensation that everything is spinning), transient loss of consciousness;
• chest pain spreading to arms, neck, jaw, back or abdomen, sweating and breathlessness, nausea or vomiting, which may be symptoms of a heart attack (myocardial infarction);
• muscle weakness, lack of energy;
• neck pain, chest pain;
• chills;
• joint swelling;
• slowed or blocked outflow of bile from the liver;
• low levels of phosphates or magnesium in the blood;
• speech difficulties;
• liver damage;
• loss of balance, difficulty moving;
• hearing loss, tinnitus (ringing in the ears);
• nerve pain, unpleasant abnormal sensations, especially in response to touch;
• excess iron in the body;
• thirst;
• confusion;
• toothache;
• falls that may lead to injury.

Uncommon adverse reactions (may affect up to 1 in 100 people):

• bleeding inside the skull;
• circulatory problems;
• loss of vision;
• loss of sex drive (libido);
• passing large amounts of urine, accompanied by bone pain and weakness, which may be symptoms of kidney disease (Fanconi syndrome);
• yellowing of the skin, mucous membranes or eyes (jaundice), pale stools, dark urine, itchy skin, rash, abdominal pain or swelling – may be symptoms of liver damage (liver failure);
• abdominal pain, bloating or diarrhoea, which may be symptoms of inflammation of the large intestine (colitis or typhlitis);
• kidney tubular cell damage (known as tubular necrosis);
• skin colour changes, sensitivity to sunlight;
• tumour lysis syndrome – metabolic complications that may occur during cancer treatment, and sometimes even without treatment. These complications are caused by products released from dying tumour cells and may include: changes in blood chemistry; high levels of potassium, phosphate, uric acid and low calcium levels, leading to kidney dysfunction, heart rhythm disturbances, seizures and sometimes death;
• high blood pressure in the blood vessels leading to the lungs (pulmonary hypertension).

Adverse reactions with unknown frequency (frequency cannot be estimated from available data):

• sudden or mild but worsening pain in the upper abdomen and/or back, lasting for several days, usually accompanied by nausea, vomiting, fever and rapid heartbeat – these symptoms may indicate pancreatitis;
• wheezing, shortness of breath or dry cough, possibly due to inflammation of lung tissue;
• rare cases of muscle breakdown (muscle pain, weakness or swelling) leading to kidney problems (rhabdomyolysis) have been observed, some occurring when Lenalidomide Fresenius Kabi was administered concomitantly with a statin (a type of medicine that lowers blood cholesterol levels);
• skin disease caused by inflammation of small blood vessels, associated with joint pain and fever (leukocytoclastic vasculitis);
• rupture of the stomach or intestinal wall, which may lead to severe infection. Inform your doctor if you experience severe stomach pain, fever, nausea, vomiting, blood in stool or changes in bowel function;
• viral infections, including varicella zoster virus (a viral disease causing a painful skin rash with blisters) and reactivation of hepatitis B virus infection (which may cause yellowing of the skin and eyes, dark brown urine, right-sided abdominal pain, fever, nausea and vomiting);
• rejection of solid organ transplant (e.g. kidney, heart).

Reporting of adverse reactions
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Lenalidomide Fresenius Kabi

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and carton following "EXP". The expiry date refers to the last day of the stated month.
There are no special storage instructions for this medicine.
Do not use this medicine if you notice any damage or signs of tampering with the packaging.
Medicines should not be disposed of via wastewater or household waste. Unused medicines should be returned to a pharmacy. This will help protect the environment.

6. Contents of the pack and other information

What Lenalidomide Fresenius Kabi contains
Lenalidomide Fresenius Kabi, 2.5 mg, hard capsules:

• The active substance is lenalidomide. Each capsule contains 2.5 mg of lenalidomide.
• The other ingredients are:
  • capsule contents: lactose, microcrystalline cellulose, sodium croscarmellose, and magnesium stearate;
  • capsule shell: gelatin, titanium dioxide (E171), indigo carmine (E132), and yellow iron oxide (E172);
  • printing ink: shellac, propylene glycol, potassium hydroxide, and black iron oxide (E172).

Lenalidomide Fresenius Kabi, 5 mg, hard capsules:

• The active substance is lenalidomide. Each capsule contains 5 mg of lenalidomide.
• The other ingredients are:
  • capsule contents: lactose, microcrystalline cellulose, sodium croscarmellose, and magnesium stearate;
  • capsule shell: gelatin and titanium dioxide (E171);
  • printing ink: shellac, propylene glycol, potassium hydroxide, and black iron oxide (E172).

Lenalidomide Fresenius Kabi, 7.5 mg, hard capsules:

• The active substance is lenalidomide. Each capsule contains 7.5 mg of lenalidomide.
• The other ingredients are:
  • capsule contents: lactose, microcrystalline cellulose, sodium croscarmellose, and magnesium stearate;
  • capsule shell: gelatin, titanium dioxide (E171), and yellow iron oxide (E172);
  • printing ink: shellac, propylene glycol, potassium hydroxide, and black iron oxide (E172).

Lenalidomide Fresenius Kabi, 10 mg, hard capsules:

• The active substance is lenalidomide. Each capsule contains 10 mg of lenalidomide.
• The other ingredients are:
  • capsule contents: lactose, microcrystalline cellulose, sodium croscarmellose, and magnesium stearate;
  • capsule shell: gelatin, titanium dioxide (E171), indigo carmine (E132), and yellow iron oxide (E172);
  • printing ink: shellac, propylene glycol, potassium hydroxide, and black iron oxide (E172).

Lenalidomide Fresenius Kabi, 15 mg, hard capsules:

• The active substance is lenalidomide. Each capsule contains 15 mg of lenalidomide.
• The other ingredients are:
  • capsule contents: lactose, microcrystalline cellulose, sodium croscarmellose, and magnesium stearate;
  • capsule shell: gelatin, titanium dioxide (E171), and indigo carmine (E132);
  • printing ink: shellac, propylene glycol, potassium hydroxide, and black iron oxide (E172).

Lenalidomide Fresenius Kabi, 20 mg, hard capsules:

• The active substance is lenalidomide. Each capsule contains 20 mg of lenalidomide.
• The other ingredients are:
  • capsule contents: lactose, microcrystalline cellulose, sodium croscarmellose, and magnesium stearate;
  • capsule shell: gelatin, titanium dioxide (E171), indigo carmine (E132), and yellow iron oxide (E172);
  • printing ink: shellac, propylene glycol, potassium hydroxide, and black iron oxide (E172).

Lenalidomide Fresenius Kabi, 25 mg, hard capsules:

• The active substance is lenalidomide. Each capsule contains 25 mg of lenalidomide.
• The other ingredients are:
  • capsule contents: lactose, microcrystalline cellulose, sodium croscarmellose, and magnesium stearate;
  • capsule shell: gelatin and titanium dioxide (E171);
  • printing ink: shellac, propylene glycol, potassium hydroxide, and black iron oxide (E172).

What Lenalidomide Fresenius Kabi looks like and contents of the pack
Lenalidomide Fresenius Kabi, 2.5 mg, hard capsules, opaque with white body and green to light green cap, approximately 14.3 mm in length, printed with "L9NL" and "2.5".
Lenalidomide Fresenius Kabi, 5 mg, hard capsules, opaque with white body and cap, approximately 18.0 mm in length, printed with "L9NL" and "5".
Lenalidomide Fresenius Kabi, 7.5 mg, hard capsules, with white body and yellow cap, approximately 18.0 mm in length, printed with "L9NL" and "7.5".
Lenalidomide Fresenius Kabi, 10 mg, hard capsules, opaque with yellow body and green to light green cap, approximately 21.7 mm in length, printed with "L9NL" and "10".
Lenalidomide Fresenius Kabi, 15 mg, hard capsules, opaque with white body and blue to light blue cap, approximately 21.7 mm in length, printed with "L9NL" and "15".
Lenalidomide Fresenius Kabi, 20 mg, hard capsules, opaque with blue to light blue body and green to light green cap, approximately 21.7 mm in length, printed with "L9NL" and "20".
Lenalidomide Fresenius Kabi, 25 mg, hard capsules, opaque with white body and cap, approximately 21.7 mm in length, printed with "L9NL" and "25".
Each cardboard box contains 7 or 21 hard capsules.

Marketing Authorisation Holder
Fresenius Kabi Polska Sp. z o.o.
Al. Jerozolimskie 134
02-305 Warsaw
Poland

Manufacturer/Importer
Synthon Hispania, S.L.
c/ Castelló, 1
08830 Sant Boi de Llobregat (Barcelona)
Spain

This medicine is authorised for marketing in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names: